Merck & Co., Inc. v. Apotex Inc., et al.

In one of the first cases decided under the Supreme Court’s new Medimmune justiciability standard, Fitzpatrick won affirmance of the dismissal of certain declaratory judgment counterclaims brought by Apotex against our client Merck. Merck markets COSOPT for the treatment of ocular hypertension and open-angle glaucoma. FDA’s Orange Book lists three patents — U.S. Patents No. 4,797,413 (the ‘413 patent), 6,248,735 (the ‘735 patent) and 6,316,443 (the ‘443 patent) — with respect to Merck’s COSOPT product. Two generic pharmaceutical companies — first Hi-Tech and then Apotex — filed abbreviated new drug applications (ANDAs) in which they sought FDA approval to market a generic version of COSOPT. Merck disclaimed the ‘735 and ‘443 patents after receiving notice of Hi-Tech’s ANDA filing, but before receiving any such notice from Apotex. Fitzpatrick successfully asserted Merck’s U.S. Patent No. 4,797,413 (the ‘413 patent) against both Hi-Tech and Apotex. As a result, both Hi-Tech and Apotex are enjoined from marketing their infringing products until after the ‘413 patent and associated pediatric exclusivity has expired.